Quadrivalent VLP Vaccine vs Placebo: Number of Participants With ≥ Severe Unsolicited TEAEs
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.00257 | 0.0015 | 0.00439 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.00493 | 0.00334 | 0.00727 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.00236 | -0.00493 | 0.0000538 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.521 | 0.267 | 1.02 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.52 | 0.266 | 1.02 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on Quadrivalent VLP Vaccine than on Placebo | 423 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | Quadrivalent VLP Vaccine | Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0. | 13 | 5,064 | OG000 | ClinicalTrials.gov |
| Group 2 | Placebo | Participants received one IM injection of 0.5 mL of placebo on Day 0. | 25 | 5,072 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Participants With ≥ Severe Unsolicited TEAEs | ClinicalTrials.gov |
| Description | The intensity of the unsolicited TEAEs was graded as mild (1)-easily tolerated and does not interfere with usual activity; moderate (2)-interferes with daily activity, but the participant is still able to function; severe (3)-incapacitating and the participant is unable to work or complete usual activity or potentially life threatening; (4)-likely to be life-threatening if not treated in a timely manner, according to the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. The ≥ Severe events included severe and potentially life-threatening events. AE and TEAEs are defined in outcome measure #10. | ClinicalTrials.gov |
| Time frame | Day 0 (post-vaccination) up to Day 21 | ClinicalTrials.gov |
| Population | SAS | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Efficacy, Safety, and Immunogenicity of a Plant-Derived Quadrivalent Virus-Like Particles (VLPs) Influenza Vaccine in Adults | ClinicalTrials.gov |
| NCT number | NCT03301051 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Virus Diseases, RNA Virus Infections, Respiratory Tract Diseases, Respiratory Tract Infections, Influenza | ClinicalTrials.gov |
| Interventions | Quadrivalent VLP Vaccine, Placebo | ClinicalTrials.gov |
| Lead sponsor | Medicago | ClinicalTrials.gov |
| Results first posted | 2023-08-14 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT03301051?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| Tables read | outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.